PDF output

XML files containing archives of each subject are saved in the specified location as intermediate output. They are used to generate a PDF file for each subject. Each file is named using the subject label. Any special characters used in subject labels will be replaced by underscores in the file names. The data within the archived files themselves will still include the special characters in the subject label.

PDF output is stored in a folder named Studyname_timestamp in the location specified in the Archive tab of the Output settings.

PDFs are created using PDF/A. This is an ISO-standardised version of PDF which is compliant with FDA regulations.

Note: If you need to archive a study containing unicode characters you must archive it to HTML as the PDF output will not display the unicode characters correctly.

Each PDF file consists of the following information:

Page Header

At the top of each page, the Study, Site and Subject identifier and Subject status is displayed.

Page Footer

At the bottom of each page, the page number is displayed.

Item Header

Above each item in the document is an item header identifying the item. The following may appear in the header, depending on the level of the item:

Visit name and cycle (if any)
Visit date
Visit status
eForm name and cycle (if any)
eForm date
eForm status
Data-item name*
Signature statement+

Bookmarks

The Bookmarks tab provides the following shortcuts to points in the document:

By Domain	All eForms in the study are listed in alphabetical order. Under each eForm is listed the visit in which that eForm appears, in order of occurrence. See example The visit items can be clicked on to jump to the eForm/visit instance in the document.
By Visit	All visits of the study are listed in order of occurrence. Under each visit is listed the eForms that appear in that visit, in alphabetical order. The eForm items can be clicked on to jump to the visit/eForm instance in the document.
Current Data	A link to the beginning of the current data section of the document.
Audit Trail	A link to the beginning of the Audit Trail section of the document.
DCRs	A link to the beginning of the DCR section of the document.
Notes	A link to the beginning of the Notes section of the document.
SDVs	A link to the beginning of the SDV section of the document.

Current Data

The current data section of the document shows the current response values of the subject. Responses are grouped into their eForms which are listed in order of occurrence. Each response appears as a table listing the data-item name, signature statement (if an electronic signature question), response value, timestamp, database timestamp, user, software version, study version, status, validation message (if any), comments (if any and if configured), reason for change (if applicable), reason for overrule. Beneath the table appear links to the response audit trail (if any), DCRs (if any), notes (if any) and/or SDVs (if any).

See example

Audit Trail

The Audit Trail section of the document shows the history of each response. Each response appears as a table listing the timestamp, database timestamp, response value, reason for change, overrule reason, user, software version, study version, status, validation message and comment. This section is only displayed after any of the above details have changed for the question.

See example

DCRs

The DCR section of the document shows an audit trail for each DCR. The data item name is also a link to the DCR’s response current data. Each DCR appears as a table listing the response value, DCR text, timestamp, user, and DCR status. This section is only displayed if at least one DCR exists for the question.

See example

Notes

The Notes section of the document shows a note audit trail for each note. The data item name is also a link to the note’s response current data. Each note appears as a table listing the response value, note text, timestamp, user, and note status. This section is only displayed if at least one note exists for the question.

See example

SDVs

The SDV section of the document shows an SDV audit trail for each SDV. The data item name is also a link to the SDV’s response current data. Each SDV appears as a table listing the response value, SDV text, timestamp, user and SDV status. This section is only displayed if at least one SDV exists for the question.

See example

PDF Blank Study Archive

If the 'Output blank study structure' option has been selected in the Output tab of the Advanced Options, a blank PDF version of the study will be created.

See example

This will be created as 'studyname annotated.pdf' where studyname is the name of the study being archived. This file will be created inside the time stamped base archive folder.

The output will be in the format of the current data with data items being grouped into their eForms, with both data items and eForms listed in order according to the study’s definition. Only the data item name and signature statement (if an electronic signature question) will be pre-filled.

Attachments

Please note that files attached to multimedia questions cannot be viewed from the PDF. They are copied into the site folder within the archive output folder but are not linked to from the PDF itself.